A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- FHI 360
- Enrollment
- 724
- Locations
- 1
- Primary Endpoint
- pregnancy
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
Detailed Description
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. It will be conducted in close collaboration with the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie Stopes Society clinics that have experience with implants and sufficient expected flow of implant users per month. We will enroll a total of 600 women divided into two cohorts in this one-year prospective study: * a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrolment; and * a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Femplant services.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible for inclusion, a woman must:
- •be aged 18-44 years, inclusive
- •be willing to sign an informed consent document
- •agree to return for follow-up visits
- •have decided to receive Femplant as a method of contraception and met the clinic criteria for eligibility of this method of contraception
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
pregnancy
Time Frame: 12 months
measure number of pregnancies while using implant
Immediate and Delayed Complications
Time Frame: 12 months
Measure Immediate and delayed complications associated with insertion or removal of implant
Adverse events
Time Frame: 12 months
to record any adverse events associated with the implant
Measure number of participants who discontinue from the study
Time Frame: 12 months
Measure number of participants who discontinue from the study and the reasons for discontinuation